Part 2 Derogations from some of the requirements in Part 1

1. 6Scope
2. 7Bibliographic application
3. 8Application for a product using a new combination of active substances
4. 9Application using existing data
5. 10Application for a pharmacologically equivalent medicinal product
6. 11Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
7. 12Extension of time limits
8. 13Parallel imports
9. 14Specific batch control scheme
10. 15Similar immunological products
11. 16Marketing in exceptional circumstances